Generics Industry News Search
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January 2014 News Archive |
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Teva Pharmaceutical announced today the launch of the Authorised Generic of Detrol LA (tolterodine tartrate extended-release capsules) 2 mg and 4 mg in the U.S. market...
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Denmark has approved the sale of a generic copy of
GlaxoSmithKline's $8 billion-a-year inhaled lung drug Advair, threatening
future sales of the British firm's biggest product...
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Mylan today announced that its
U.S. based subsidiary Mylan Pharmaceuticals has launched Tolterodine Tartrate
Extended-release (ER) Capsules, 2 mg and 4 mg...
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Drug maker Ranbaxy today announced receipt of approval from Health Canada to sell generic version of Pfizer's Aricept, a drug used for treatment of dementia in Alzheimer's patients...
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Actavis today announced that it has received approval from the U.S. FDA
on its ANDA for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg,
a generic equivalent to Boehringer Ingelheims Micardis...
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Ranbaxy Laboratories and EPIRUS Switzerland GmbH, a wholly-owned
subsidiary of Boston-based Epirus Biopharmaceuticals announced the signing of a
licensing agreement for BOW015, a biosimilar version of Infliximab...
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Mylan today announced that its U.S.-based subsidiary Mylan
Pharmaceuticals has launched Mycophenolic Acid Delayed-release Tablets, 180 mg
and 360 mg...
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The U.S. Food and Drug Administration and the European Medicines Agency have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals...
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Zydus Cadila received the final approval from the USFDA to market Sirolimus tablets 0.5 mg with 180 days of marketing exclusivity...
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Aurobindo Pharma is in talks with global pharma giant
Actavis to buy their API units in Western Europe, sources familiar with the
development suggest...
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Germany approved the sale of a generic version of GlaxoSmithKline's Advair on Monday, becoming the second country in Europe to authorise a copy of the top-selling inhaled lung drug...
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Teva today announced the publication of data that demonstrates significant differences in biological and immunological effects between Copaxone (Glatiramer acetate, GA) and a purported generic Glatiramer acetate (GA), marketed in India, (Glatiramer, Natco, Hyderabad, India), with potential clinical ramifications...
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For years, members of the pharmaceutical industry have awaited the release of what has been dubbed by many as "The Social Media Guidance," a document intended to explain in full detail how companies could use social media platforms to advertise and promote their products while meeting the USFDA's strict regulatory requirements...
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Drugmakers Valeant, Actavis and Mylan have all expressed interest in buying Pfizer's branded generics business, but no active discussions are going on at this time, according to three people close to the matter...
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Denmark's Novo Nordisk has been sued by a group of healthcare purchasing
companies in the United States for allegedly wrongfully keeping generic
copies of its Prandin diabetes drug off the market...
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A federal judge said Teva Pharmaceutical Industries did not
infringe five patents related to the painkiller OxyContin, helping push shares
of the world's largest generic drug manufacturer up 6.7 per cent on Tuesday...
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A Texas judge has upheld U.S. patents covering Allergan's Lumigan glaucoma drug through 2027, the company said in a regulatory
filing on Tuesday, helping to send its shares up 6 per cent...
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Perrigo today announced that it has received final approval for its abbreviated new drug application for Fluocinonide cream 0.1%, the generic equivalent to Vanos cream 0.1%...
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Britain's Vectura said on Tuesday its partner Sandoz, the generics division of Switzerland's Novartis, had received Swedish authorisation for its generic version of the drug, known as AirFluSal Forspiro...
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Drug maker Ranbaxy is learnt to have partnered another
multinational pharmaceuticals company for sourcing API, for the generic version
of anti-hypertension drug Diovan...
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Actavis, the second-biggest generic drug maker by market capitalization, said it will end its presence in China because of the difficult business climate...
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Par Pharmaceutical today announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma to distribute the authorized generic version of Covis's Lanoxin (digoxin) tablets...
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Johnson & Johnson today announced that it has received a binding offer from The Carlyle Group to acquire its Ortho-Clinical Diagnostics business for $4.15 Billion...
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Celltrion has received approval in its home market of South Korea for Herzuma, a biosimilar of Roche's blockbuster Herceptin...
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Heritage announced the immediate availability of Prochlorperazine edisylate injection in the 5mg/mL strength...
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Ariad today announced the commercial availability of Iclusig (Ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States...
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Actavis today confirmed that the United States District Court for the
District of New Jersey found United States Patent No. 7,704,984 (the
'984 Patent) to be valid and infringed by Lupin and Amneal Abbreviated
New Drug Applications for generic versions of Actavis' Lo
Loestrin Fe (Norethindrone acetate and Ethinyl estradiol tablets,
Ethinyl estradiol tablets and ferrous fumarate tablets)...
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Aurobindo today announced the signing of a binding offer to acquire commercial operations in seven Western European countries from Actavis...
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Biocon, Asia's premier biotechnology company, today introduced CANMAb (150 mg/ 440 mg), a biosimilar Trastuzumab for the treatment of HER2-positive metastatic breast cancer in India...
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Drug major Zydus Cadila has received approval from the US health regulator to market Bupropion hydrochloride extended-release tablets, an anti-depressant medicine, in the American market...
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Teva today announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash, or approximately $144 million...
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Par Pharmaceutical today announced that it has entered into a definitive agreement to acquire JHP Group Holdings, the parent company of JHP Pharmaceuticals, a leading specialty pharmaceutical company that develops, manufactures and markets branded and generic sterile injectable products....
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Teva is making one last desperate plea to the U.S. Supreme Court. The Israel-based drug maker has asked SCOTUS to review a lower court's decision to invalidate key patents on its top-selling drug, Copaxone....
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Indian drug makers are eager to enter the generic inhaler combination business in the US after the drug regulator there eased guidelines for cheaper alternatives to GSK's blockbuster respiratory drug, Advair....
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Actavis today confirmed that its subsidiary, Watson Laboratories, has submitted an ANDA with the U.S. FDA seeking approval to market a generic version of Allergan's Restasis ...
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Evoke Pharma said its inhaled version of a generic gastrointestinal drug was found to be superior in managing symptoms of bowel disease compared with the existing oral treatment, sending its shares up 45 per cent...
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The Intellectual Property Appellate Board (IPAB) has asked the patent office to consider afresh a matter related to the patent application of US-based Abraxis BioScience for its anti-cancer drug Abraxane, following pre-grant opposition by Hyderabad-based Natco Pharma...
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Unichem Laboratories has received approval from the US FDA to sell generic Metronidazole tablets, an anti-infective agent, in the American market....
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Aurobindo Pharma has received final approval from the US FDA to manufacture and market generic Repaglinide tablets that are used as an adjunct to diet in diabetic patients....
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Hi-Tech Pharmacal, a specialty pharmaceuticals company, announced today that the US FDA granted final approval for the Company's ANDA for Bromfenac Ophthalmic Solution...
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Mylan today announced that its U.S.-based subsidiary Mylan Pharmaceuticals has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg...
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Perrigo today announced that it has received final approval from the U.S. Food & Drug Administration for its abbreviated new drug application for Repaglinide tablets 1 mg and 2 mg, the generic equivalent to Prandin tablets (Repaglinide tablets) and has commenced shipment of product...
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Novartis is still in the midst of defining what it will be going forward, but 2014 looks to be another year of transition for the Swiss drug maker. It now expects the long-delayed U.S. release of a generic of its blockbuster Diovan to happen in the second quarter and by summers end hopes to have completed the strategic review that will decide the fate of several of its operating units...
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Depomed announced today a favourable "Markman" claim construction ruling by Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey in Depomed's ongoing patent infringement case against filers of three ANDAs seeking to market generic versions of Depomed's Gralise (Gabapentin) product prior to the expiration of Depomed's patents listed for Gralise in the FDA's Orange Book...
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Endo today confirmed that the U.S. District Court for the District of Delaware ruled that U.S. Patent No. 5,464,864, Endo's patent covering Frovatriptan...
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Drug making multinationals Merck along with Bristol Myers Squibb have settled a law suit with Indian generics player Aurobindo Pharma which wanted to sell the copy cat version of their drug before the patent expires...
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Idenix, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the USPTO Patent Trial and Appeal Board issued a decision in the first patent interference proceeding...
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Watchdog Drug Controller General of India will soon begin inspecting Ranbaxy's plants in India to test these for manufacturing practices and hygiene norms in the latest string of run-ins with regulators faced by the generic pharmaceuticals company...
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Sanofi announced today that it filed a patent infringement suit against Eli Lilly on January 30, 2014 in the U.S. District Court for the District of Delaware. In its suit Sanofi alleges infringement of four patents...
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The Board of Directors of Glenmark Pharmaceuticals, in their meeting held on January 31, 2014, have approved a proposal to merge its subsidiaries i.e. Glenmark Generics and Glenmark Access with Glenmark Pharmaceuticals...
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On January 30, 2014, Cadence announced that it had entered into a settlement agreement with Sandoz to resolve pending patent litigation in regard to Ofirmev...
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Forest, Merz and Adamas have jointly filed a lawsuit in the U.S. District Court for the District of Delaware against several companies for infringement of some or all of U.S. Patent...
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